"Please, do not make us suffer any more…"

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Executive Summary

"For two days I had agonizing pain in both the back and
front of my body. I thought I was going to die. The doctor said that there was
no need to medicate my pain, that it was just a hematoma and that the pain
would go away by itself. I was screaming all through the night."

– An Indian man describing his stay in hospital immediately
after a construction site accident in which he sustained spinal cord trauma.[1]

"Cancer is killing us. Pain is killing me because for
several days I have been unable to find injectable morphine in any place.
Please Mr. Secretary of Health, do not make us suffer any more…"

– A classified ad placed in a Colombian newspaper in September
2008 by the mother of a woman with cervical cancer.[2]

"Physicians are afraid of morphine… Doctors [in Kenya]
are so used to patients dying in pain…they think that this is how you must die.
They are suspicious if you don't die this way – [and feel] that you died
prematurely."

In 1961, the world community adopted an international
agreement-the 1961 Single Convention on Narcotic Drugs-that proclaimed
"narcotic drugs…indispensible for the relief of pain and suffering" and
instructed countries to make adequate provision to ensure their availability
for medical needs. Today, almost fifty years later, the promise of that
agreement remains largely unfulfilled, particularly-but not only-in low and
middle income countries. In September 2008, the World Health Organization (WHO)
estimated that approximately 80 percent of the world population has either no
or insufficient access to treatment for moderate to severe pain and that every
year tens of millions of people around the world, including around four million
cancer patients and 0.8 million HIV/AIDS patients at the end of their lives
suffer from such pain without treatment.

The poor availability of pain treatment is both perplexing
and inexcusable. Pain causes terrible suffering yet the medications to treat it
are cheap, safe, effective and generally straightforward to administer.
Furthermore, international law obliges countries to make adequate pain
medications available. Over the last twenty years, the WHO and the International
Narcotics Control Board (INCB), the body that monitors the implementation of
the UN drug conventions, have repeatedly reminded states of their obligation.
But little progress has been made in many countries.

Under international human rights law, governments must
address a major public health crisis that affects millions of people every
year. They must take steps to ensure that people have adequate access to
treatment for their pain. At a minimum, states must ensure availability of
morphine, the mainstay medication for the treatment of moderate to severe pain,
because it is considered an essential medicine that should be available to all
persons who need it and is cheap and widely available. Failure to make
essential medicines available or to take reasonable steps to make pain
management and palliative care services available will result in a violation of
the right to health. In some cases, failure to ensure patients have access to
treatment for severe pain will also give rise to a violation of the prohibition
of cruel, inhuman and degrading treatment.

There are many reasons for the enormity of the gap between
pain treatment needs and what is delivered, but chief among them is a shocking
willingness by many governments around the world to passively stand by as
people suffer. Few governments have put in place effective supply and
distribution systems for morphine; they have no pain management and palliative
care policies or guidelines for practitioners; they have excessively strict
drug control regulations that unnecessarily impede access to morphine or
establish excessive penalties for mishandling it; they do not ensure healthcare
workers get instruction on pain management and palliative care as part of their
training; and they do not make sufficient efforts to ensure morphine is
affordable. Fears that medical morphine may be diverted for illicit purposes
are a key factor blocking improved access to pain treatment. While states must
take steps to prevent diversion, they must do so in a way that does not unnecessarily
impede access to essential medications. INCB has stated that such diversion is relatively
rare.[4]

In many places, these factors combine to create a vicious
cycle of under-treatment: because pain treatment and palliative care are not
priorities for the government, healthcare workers do not receive the necessary
training to assess and treat pain. This leads to widespread under-treatment and
to low demand for morphine. Similarly, complex procurement and prescription
regulations and the threat of harsh punishment for mishandling morphine
discourage pharmacies and hospitals from stocking and healthcare workers from
prescribing it, again resulting in low demand. This, in turn, reinforces the
low priority given to pain management and palliative care. This low
prioritization is not a function of low prevalence of pain but of the
invisibility of its sufferers.

To break out of this vicious cycle, individual governments
and the international community must fulfill their obligations under
international human rights law. Governments must take action to eliminate
barriers that impede availability of pain treatment medications. They must
develop policies on pain management and palliative care; introduce instruction
for healthcare workers, including for those already practicing; reform
regulations that unnecessarily impede accessibility of pain medications; and
take action to ensure their affordability. While this is a considerable task,
various countries, such as Romania, Uganda and Vietnam, have shown that such a
comprehensive approach is feasible in low and middle-income countries and can
be successful. In pursuing steps to improve pain treatment, countries should
draw on the expertise and assistance of the WHO Access to Controlled
Medications Programme and INCB.

The international community should address the poor
availability of pain treatment with urgency. The UN General Assembly Special
Session on Drugs that will take place in Vienna in March 2009 is a unique
opportunity to begin to do so. At the meeting, which will conclude a year-long
review of the last ten years of drug policy, countries will set priorities for
the next ten years of global drug policy. In Vienna, the international
community should recommit itself to the mandate of the 1961 Single Convention
for states to ensure adequate availability of controlled medicines for the
relief of pain and suffering. For too long, the global drug policy debate has
been strongly focused on prevention of the use and trade of illicit drugs,
distorting the balance that was envisioned by the Convention. In March 2009,
the international community should set ambitious and measurable goals to
significantly improve access to opioid analgesics-pain medications made from
opiates-and other controlled medicines worldwide over the coming ten years.

After March 2009, global drug policy actors, such as the UN
Commission on Narcotic Drugs and INCB, should regularly review progress made by
countries toward adequate availability of pain treatment medications, carefully
analyzing steps taken to advance this important issue. Donor countries and
agencies, including the Global Fund to fight AIDS, Malaria, and Tuberculosis
and the U.S. President's Emergency Plan for AIDS Relief, should actively
encourage countries to undertake comprehensive steps to improve access to pain
relief medications and support those that do, including through support for the
WHO Access to Controlled Medications Programme. UN and regional human rights
bodies should routinely remind countries of their obligation under human rights
law to ensure adequate availability of pain medications.

Background: Pain in the
World Today

Prevalence of Pain

Chronic moderate and severe pain is a common symptom of
cancer and HIV/AIDS, as well as of various other health conditions.[5]
A recent review of pain studies in cancer patients found that more than fifty
percent of cancer patients experience pain symptoms[6]
and research consistently finds that 60 to 90 percent of patients with advanced
cancer experience moderate to severe pain.[7] The intensity of
the pain and its effect vary depending on to the type of cancer, treatment, and
personal characteristics. Prevalence and severity of pain usually increase with
disease progression.

Although no population-based studies of AIDS-related pain have
been published, multiple studies report that 60 to 80 percent of patients in
the last phases of illness experience significant pain.[8]
Even though the increasing availability of antiretroviral drugs in middle and
low income countries is prolonging the lives of many people with HIV, pain
symptoms continue to be a problem for a significant proportion of these
patients.[9]
Several studies have found that between 29 and 74 percent of people who receive
antiretroviral treatment experience pain symptoms.[10]

Experts believe that worldwide there are 24.6 million people
who suffer from cancer annually, and that more than 7 million people die of it
every year. Overall, 12 percent of all deaths worldwide are due to cancer.[11],[12]
WHO warns that these numbers will continue to grow over the coming years, with
30 million people projected to be living with cancer by 2020.[13]
UNAIDS estimates that about 32 million people live with HIV worldwide, that
some 4.1 million people are newly infected each year, and that almost 3 million
die of the disease.[14],[15]

The Impact of Pain

Moderate to severe pain has a profound impact on quality of
life. Scientific research has demonstrated that persistent pain has a series of
physical, psychological and social consequences. It can lead to reduced mobility
and consequent loss of strength; compromise the immune system; interfere with a
person's ability to eat, concentrate, sleep, or interact with others.[16]
The psychological consequences are also profound. A WHO study found that people
who live with chronic pain are four time more likely to suffer from depression
or anxiety.[17]
The physical effect of chronic pain and the psychological strain it causes can
even influence the course of disease. According to WHO, "[p]ain can kill..."[18]

Pain has social consequences for people experiencing it and
often also for their care givers, who may face sleep deprivation and other
problems as a result. These social consequences include inability to work, care
for children or other family members, and participate in social activities.[19]
Pain can also interfere with a dying person's ability to bid farewell to loved
ones and make final arrangements.

While the physical, psychological and social consequences of
pain are measurable, the suffering caused by the pain is not. Yet, there can be
little dispute about enormity of the misery it inflicts. People who experience
severe but untreated pain often live in agony for much of the day and often for
extended periods of time. Many people interviewed by Human Rights Watch who
had experienced severe pain in India, expressed the exact same sentiment as
torture survivors: all they wanted was for the pain to stop. Unable to sign a
confession to make that happen, several people told us that they had wanted to
commit suicide to end the pain, prayed to be taken away, or told doctors or
relatives that they wanted to die.[20]

Pain Management:
Elements, Effectiveness, Cost

According to WHO, "Most, if not all, pain due to cancer could
be relieved if we implemented existing medical knowledge and treatments."[21]
The mainstay medication for the treatment of moderate to severe pain is
morphine, an opioid that is made of an extract of the poppy plant. Morphine can
both be injected and taken orally. It is mostly injected to treat acute pain,
generally in hospital settings. Oral morphine is the drug of choice for chronic
pain, and can be taken both institutional settings and at home. Due to the
potential for its abuse, morphine is a controlled medication, meaning that its
manufacture, distribution and dispensing is strictly controlled both at the
international and national levels.

The WHO Pain Relief Ladder is the basis for modern pain
management. Originally developed for treating cancer pain, it has since been
applied successfully to HIV/AIDS-related pain.[22] The ladder
recommends the administration of different types of pain medications, or
analgesics, according to the severity of the pain. For mild pain, it calls for
basic pain relievers like acetaminophen (Tylenol), aspirin, or nonsteroidal
anti-inflammatory drugs that are usually widely available and without
prescription. For mild to moderate pain, it recommends a combination of basic
pain relievers and a weak opioid, like codeine. For moderate to severe pain, it
calls for strong opioids, like morphine. Indeed, WHO has held that for managing
cancer pain, opioids are "absolutely necessary" and, when pain is moderate to
severe, "there is no substitute for opioids" such as morphine."[23]
The Pain Relief Ladder also recommends various other medications, known as adjuvant
drugs, that serve to increase the effectiveness of analgesics or counter their
side effects, including laxatives, anti-convulsants and anti-depressants.

Pain medications vary greatly in terms of cost. Basic oral
morphine in powder or tablet form is not protected by any patent and can be
produced for as little as US$0.01 per milligram.[24]
(A typical daily dose in low and middle-income countries ranges, according to
one estimate, from 60 to 75 milligrams per day).[25]
Other pain medications, such as Fentanyl skin patches that gradually release
the active substance, are very costly, and some protect by patent. Because oral
morphine can be produced cheaply, providing pain management should be possible
at the community level even in developing countries. However, a 2004 study by
De Lima and others found that, for a variety of reasons (see below, under
Cost), opioid analgesics, including basic oral morphine, tend to be
considerably more expensive in both relative and absolute terms in low and
middle income countries than in industrialized nations.[26]

Chronic pain management often comes as a part of broader
palliative care services. Palliative care aims to improve the quality of life
of patients and their families facing problems associated with life-threatening
illnesses, through the prevention and relief of suffering by means of early
identification and impeccable assessment and treatment of pain and other
problems, physical, psychosocial and spiritual.[27]
The World Health Organization recognizes palliative care as an essential
component of a national response to HIV/AIDS, cancer and other diseases.[28]
The organization estimates that,

despite an overall 5-year survival rate of nearly 50% in
developed countries, the majority of cancer patients will need palliative care
sooner or later. In developing countries, the proportion requiring palliative
care is at least 80%. Worldwide, most cancers are diagnosed when already
advanced and incurable.[29]

For those with incurable cancers, the only realistic
treatment options are pain relief and palliative care.[30]
Palliative care is often provided alongside curative care services.[31]
While palliative care providers may offer inpatient services at hospices or
hospitals, their focus is frequently on home-based care for people who are terminally
ill or have life-limiting conditions, thus reaching people who otherwise might
not have any access to healthcare services, including pain management.

Widespread Consensus:
Pain Relief Medications Must Be Available

For decades, there has been a consensus among health experts
that opioid pain relievers like morphine and codeine must be available for the
treatment of moderate and severe pain. Almost fifty years ago, UN member states
articulated that consensus as follows when they adopted the 1961 Single
Convention on Narcotic Drugs:

The medical use of narcotic drugs continues to be
indispensable for the relief of pain and suffering and adequate provision must
be made to ensure the availability of narcotic drugs for such purposes.[32]

The International Narcotic Control Board, the body charged
with overseeing the implementation of the UN drug conventions, clarified in
1995 that the Convention "establishes a dual drug control obligation: to ensure
adequate availability of narcotic drugs, including opiates, for medical and
scientific purposes, while at the same time preventing illicit production of,
trafficking in and use of such drugs."[33]

The World Health Organization has included both morphine and
codeine in its Model List of Essential Medicines, a list of the minimum
essential medications that should be available to all persons who need them.
WHO has also repeatedly stated that palliative care and pain treatment are an
essential-not optional-component of care for cancer and HIV/AIDS. For example,
in its guide on the development of national cancer control programs it observes
that "a national disease control plan for AIDS, cancer and noncommunicable
disorders cannot claim to exist unless it has an identifiable palliative care
component."[34]

Over the last twenty years, the INCB, WHO and other
international bodies have repeatedly reminded countries of their obligation to
ensure adequate availability of opioids for the treatment of pain.

·In 1986, the WHO recommended the use of oral
morphine for treatment of long term pain.

·In 1989, INCB made a series of
recommendations to states on the need to improve availability of opioid
analgesics.[35]

·In 1994/5, it conducted a survey to identify
obstacles to improving such availability and assess the response of member states
to its 1989 recommendations.[36]

·In 1987 and 1996, the WHO issued guides to
cancer pain relief with recommendations for countries on improving opioid
analgesic availability.[37]

·In 1999, INCB devoted a chapter in its
annual report to the issue.[38]

·In 2000, WHO developed a tool for
governments and providers to use in evaluating national opioid control policies
and recommendations on improving availability.[39]

·In 2007, in consultation with INCB, WHO
established the Access to Controlled Medications Programme, which aims to
address all identified impediments to accessibility of controlled medicines,
with a focus on regulatory, attitude and knowledge impediments.[40]

In its annual reports, INCB routinely expresses concern
about the poor availability of pain treatment medications in many countries and
calls on member states to take further steps. Various other international
bodies, such as the UN Economic and Social Council and the World Health
Assembly, have also called on countries to ensure adequate availability of opioid
analgesics.[41]

The Pain Treatment Gap

"Most, if not all, pain due to cancer could be relieved if
we implemented existing medical knowledge and treatments…There is a treatment
gap: it is the difference between what can be done, and what is done about cancer
pain." – World Health Organization[42]

Despite the clear consensus that pain treatment medications
should be available, approximately 80 percent of the world population has
either no or insufficient access to treatment for moderate to severe pain and tens
of millions of people around the world, including around four million cancer
patients and 0.8 million end-stage HIV/AIDS patients, suffer from moderate to
severe pain each year without treatment, according to the World Health
Organization.[43]
Approximately 89 percent of the total world consumption of morphine occurs in
countries in North America and Europe.[44] Low and middle
income countries consume only 6 percent of the morphine used worldwide[45]-while
having about half of all cancer patients[46] and 95 percent of
new HIV infections.[47]
Thirty-two countries in Africa have almost no morphine distribution at all,[48]
and only fourteen have oral morphine.[49]

However, inadequate pain management is also prevalent in
developed countries. In the United States, an estimated 25 million people
experience acute pain as a result of injury or surgery, and between 70 and 90
percent of advanced cancer patients experience pain. Surveys of subjects
ranging from children to elderly patients have shown that over one third are
not adequately treated for pain.[50]
Lack of access to pain medication in pharmacies and fear of addiction on the
part of both patients and providers are significant limiting factors in the
United States.[51]
Studies in Western Europe also document under-treatment of pain. A study of
people living with HIV in France found that doctors underestimated pain
severity in over half of their patients and under-prescribed both opioids and
antidepressants.[52]

Up to 85 percent of people living with HIV have untreated
pain, twice the proportion of people with cancer whose pain is untreated.[53]
A study in the U.S. found that less than 8 percent of AIDS patients who
reported severe pain were treated according to official treatment guidelines,
and women, less-educated patients, and patients with histories of injection
drug use were most likely to report inadequate treatment for pain.[54]

Pain Treatment,
Palliative Care and Human Rights

Health as a Human Right

Health is a fundamental human right enshrined in numerous
international human rights instruments.[55] The International
Covenant on Economic Social and Cultural Rights (ICESCR) specifies that
everyone has a right "to the enjoyment of the highest attainable standard of
physical and mental health." The Committee on Economic, Social and Cultural
Rights, the body charged with monitoring compliance with the ICESCR, has held
that states must make available in sufficient quantity "functioning public
health and health-care facilities, goods and services, as well as programmes"
and that these services must be accessible.

Because states have different levels of resources,
international law does not mandate the kind of health care to be provided. The
right to health is considered a right of "progressive realization." By becoming
party to the international agreements, a state agrees "to take steps… to the
maximum of its available resources" to achieve the full realization of the
right to health. In other words, high income countries will generally have to
provide healthcare services at a higher level than those with limited
resources. But all countries will be expected to take concrete steps towards
increased services, and regression in the provision of health services will, in
most cases, constitute a violation of the right to health.

But the Committee on Economic, Social and Cultural Rights
has also held that there are certain core obligations that are so fundamental
that states must fulfill them. While resource constraints may justify only
partial fulfillment of some aspects of the right to health, the Committee has
observed vis-à-vis the core obligations that "a State party cannot, under any
circumstances whatsoever, justify its non-compliance with the core
obligations…, which are non-derogable." The Committee has identified, among
others, the following core obligations:

·To ensure the right of access to health
facilities, goods and services on a non-discriminatory basis, especially for
vulnerable or marginalized groups;

·To provide essential drugs, as from time to
time defined under the WHO Action Programme on Essential Drugs;

·To adopt and implement a national public
health strategy and plan of action, on the basis of epidemiological evidence,
addressing the health concerns of the whole population.[56]

Pain Treatment and the
Right to Health

As morphine and codeine are on the WHO List of Essential
Medicines, countries have to provide these medications as part of their core
obligations under the right to health, regardless of whether they have been
included on their domestic essential medicines lists.[57]
They must make sure that they are both available in adequate quantities and
physically and financially accessible for those who need them.

In order to ensure availability and accessibility, states
have, among others, the following obligations:

·Since manufacturing and distribution of
controlled medicines like morphine and codeine are completely in government
hands, states must put in place an effective procurement and distribution system
and create a legal and regulatory framework that enables healthcare providers
in both the public and private sector to obtain, prescribe and dispense these
medications. Any regulations that arbitrarily impede the procurement and
dispensing of these medications will violate the right to health.

·States must adopt and implement a strategy
and plan of action for the roll out of pain treatment and palliative care
services. Such strategy and plan of action should identify obstacles to
improved services as well as steps to eliminate them.

·States should regularly measure progress
made in ensuring availability and accessibility of pain relief medications.

·The requirement of physical accessibility
means that these medications must be "within safe physical reach for all
sections of the population, especially vulnerable or marginalized groups, such
as…persons with HIV/AIDS."[58]
This means that states must ensure that a sufficient number of healthcare
providers or pharmacies stock and dispense morphine and codeine, and that an
adequate number of healthcare workers are trained and authorized to prescribe
these medications.

·Financial accessibility means that, while
the right to health does not require states to offer medications free of
charge, they must be "affordable for all."[59] In the words of
the Committee:

Payment for health-care
services…has to be based on the principle of equity, ensuing that these
services, whether privately or publicly provided, are affordable to all,
including socially disadvantaged groups. Equity demands that poorer households
should not be disproportionately burdened with health expenses as compared to
richer households.[60]

Countries also have an obligation to progressively implement
palliative care services, which, according to WHO, must have "priority status
within public health and disease control programmes."[61]
Countries must ensure an adequate policy and regulatory framework, develop a
plan for implementation of these services, and take all steps that are
reasonable within available resources to execute the plan. Failure to attach
adequate priority to developing palliative care services within healthcare
services will violate the right to health.

Pain Treatment and the
Right to Be Free from Cruel, Inhuman and Degrading Treatment

The right to be free from torture, cruel, inhuman and
degrading treatment or punishment is a fundamental human right that is
recognized in numerous international human rights instruments.[62]
Apart from prohibiting the use of torture, cruel, inhuman, and degrading
treatment or punishment, the right also creates a positive obligation for
states to protect persons in their jurisdiction from such treatment.[63]

As part of this positive obligation, states have to take
steps to protect people from unnecessary pain related to a health condition. As
the UN Special Rapporteur on Torture, Cruel, Inhuman and Degrading Treatment
and Punishment wrote in a joint letter with the UN Special Rapporteur on the
Right to Health to the Commission on Narcotic Drugs in December 2008,

Governments also have an obligation to take measures to
protect people under their jurisdiction from inhuman and degrading treatment.
Failure of governments to take reasonable measures to ensure accessibility of
pain treatment, which leaves millions of people to suffer needlessly from
severe and often prolonged pain, raises questions whether they have adequately
discharged this obligation.[64]

Obstacles to Provision
of Pain Treatment and Palliative Care

There is no lack of information about the reasons why so
many people who suffer from severe pain cannot get access to adequate pain
treatment. In dozens of publications spanning several decades, the World Health
Organization, the International Narcotics Control Board, healthcare providers,
academics and others have chronicled the barriers in great detail.[65]
A common theme of many of these publications is the failure of many governments
around the world to take reasonable steps to improve access to pain treatment
and palliative care services and to strike the right balance between ensuring
availability of controlled medications for legitimate purposes and preventing
their abuse.

In its 2007 Annual Report, the INCB repeated its previous
calls for improvement:

The low levels of consumption of opioid analgesics for the
treatment of pain in many countries…continue to be a matter of serious concern
to the Board. The Board again urges all Governments concerned to identify the
impediments in their countries to adequate use of opioid analgesics for the
treatment of pain and to take steps to improve the availability of those
narcotic drugs for medical purposes...[66]

To date, these calls have largely fallen on deaf ears.
Because of countries' failure to act on the recommendations of WHO and INCB,
many of the same obstacles that the organizations identified two decades ago
remain today.

These barriers include the failure of many governments to
put in place functioning drug supply systems; the failure to enact policies on
pain treatment and palliative care; the existence of unnecessarily restrictive
drug control regulations and practices; fear among healthcare workers of legal
sanctions for legitimate medical practice; poor training of healthcare workers;
and the unnecessarily high cost of pain treatment.

While there is no doubt that it will not be easy to overcome
some of these barriers and implement comprehensive pain treatment and
palliative care services, particularly for countries with limited resources,
much progress could be made if governments took the action required of them by international
human rights standards and the UN drug conventions. Indeed, the governments of
countries like Romania, Uganda and Vietnam-each of which have adopted
comprehensive approaches to improving availability of pain treatment-have shown
that much can be done to comply with the basic standards required, even by
countries with limited resources. While each of these countries still has much
to do to make pain treatment and palliative care fully available they are all
moving in the right direction.

Failure to Ensure
Functioning and Effective Supply System

Opioid analgesics are controlled medicines. As such, their
manufacture, distribution and prescription are strictly regulated; these
medications cannot be traded freely on the market. The 1961 Single Convention
on Narcotic Drugs has created a system to regulate supply and demand. Every
year, countries submit estimates of their need for morphine and other
controlled medications to INCB, which then approves a quota for countries and
authorizes producing countries to grow a specified amount of raw material. Once
INCB has approved their quota, countries may then purchase morphine up to the
approved amount. Each individual transaction across international borders must
be authorized and registered by INCB. On a national level, special drug control
agencies are responsible for communicating with INCB about the need for
morphine, imports and exports, and for regulating and overseeing all domestic
transactions involving controlled medications.

Under the UN drug conventions, countries have an obligation
to ensure a functioning and effective supply system for controlled medications.
The INCB has held that

…an efficient national drug control regime must involve not
only a programme to prevent illicit trafficking and diversion but also a
programme to ensure the adequate availability of narcotic drugs for medical and
scientific purposes.[67]

Such drug availability programs must be capable of ensuring
that adequate amounts of morphine and other controlled medicines are available
in the country at any given time, that an effective system of distribution is
in place to provide healthcare providers and pharmacies with a continuous and
adequate supply of the medications, and that a sufficient number of pharmacies
and health facilities stock them so that healthcare providers and patients
around the country can reasonably gain access to them at need. As the World
Health Organization has noted, good communication between health workers and
drug regulators is crucial to meet these goals.[68]

Because the production, distribution and dispensing of
controlled medicines is under exclusive government control, governments have a
particularly strong responsibility to ensure their availability and
accessibility. With medications that are not controlled, private actors,
including healthcare providers, pharmaceutical companies and nongovernmental
organizations, can produce or import medications themselves without limited or
no government facilitation. That is not the case with controlled medications–if
a government does nothing to ensure an adequate supply and a functioning
distribution system, they will simply not be legally available.

Yet, many governments, particularly in low and middle income
countries, have failed to put in place functioning and effective supply systems
for controlled medicines. Indeed, judging by the fact that in dozens of
countries almost no morphine is used, it appears that many do not have a
functioning supply system at all. In 1999, the INCB noted that this is not just
the result of resource limitations but also of "a lack of determination on the
part of Governments and their services."[69]

Research that the African Palliative Care Association (APCA)
conducted in 2006 illustrates the lack of commitment of some African countries
to ensuring availability of controlled medicines. The organization tried to
conduct a survey among palliative care providers and drug control authorities
in twelve African countries to identify challenges in implementation of
palliative care and pain treatment services. The organization succeeded in
securing the participation of drug control agencies in five of the twelve
target countries in the survey.

The survey findings suggest a considerable disconnect
between drug control authorities and the healthcare system. Three of the five
drug control agencies-from Kenya, Tanzania and Ethiopia-stated that they
believed the regulatory system worked well, even though morphine consumption in
each of these countries is far below estimated need and the palliative care
providers surveyed identified myriad problems with the regulatory system.[70]

Furthermore, the survey suggested that drug control agencies
in each of the five countries listed controlled medicines as available in
healthcare settings when none of the palliative care providers actually had
access to them. In its report, APCA wrote:

In every country without exception INCB competent
authorities cited specific opioids that they believed to be available
in-country that were never cited by any [palliative care] service within that
country.[71]

Estimating National
Need

Many countries do not submit estimates for their need for
controlled substances based upon careful assessment of population needs to the
INCB, as required by the UN drug conventions. Some countries submit no estimate
or estimates that are only symbolic in nature. For example, the West African
nation of Burkina Faso estimated that it will need 49 grams of morphine in
2009.[72]
Using Foley's estimate that the average terminal cancer or AIDS patient who
suffers from severe pain will need 60 to 75mg of morphine per day for an
average of about 90 days, this amount would suffice for about 8 patients. As a
result, countries like Burkina Faso receive quotas from INCB for morphine that
are so low that they cannot possibly ensure adequate availability of morphine
for pain treatment in the country.[73]

Many other countries submit estimates that vastly understate
the actual medical need for morphine. Often, these estimates are not based on
actual need but on morphine consumption during the previous year. Some
countries appear to simply reproduce the same estimate each year, regardless of
demographic changes or true estimates of need.[74]

Figure 1. Morphine Estimates, Mortality, and Pain Treatment Need *

Country

Cancer Deaths 2002 Estimate

AIDS Deaths 2005 Estimate

# of individuals expected to Need Pain
Treatment in 2009

Estimated total morphine need in 2009
(kgs)

Estimate of morphine need provided by
country to INCB for 2009 (kgs)

# of individuals estimate is sufficient
for

Percentage of those needing treatment who
would be covered by estimate

Countries that estimate almost no need
for morphine

Benin

13490

9986

15786

96

0.5

83

0.50%

Senegal

17625

5432

16816

102

0.6

99

0.60%

Rwanda

14196

21956

22335

136

0.8

132

0.60%

Gambia

2395

1430

2631

16

0.18

31

1.20%

Bhutan

727

<10 per 100,000

582

3.5

0.08

14

2.30%

Burkina Faso

23262

13067

25143

153

0.05

8

0.03%

Eritrea

6240

5959

7972

48

0.075

12

0.15%

Gabon

2071

4457

3886

24

0.088

14

0.40%

Swaziland

1837

17577

10258

62

0.5

82

0.80%

Selected other countries

Egypt

62299

<10 per 100,000

49840

303

10

1646

3%

Philippines

78500

<10 per 100,000

62800

382

31

5103

8%

Kenya

50809

149502

115398

701

30

4938

4%

Russian Federation

217696

N/A

174157

1058

200

32922

15%

Mexico

92701

6321

77321

470

180

29630

38%

* The purpose of this figure is to illustrate the gross
inadequacy of estimates for medical need submitted to INCB by many countries.
The projection for the numbers of people requiring pain treatment does not
include persons with pain related to non-terminal cancer or HIV, acute pain, or
chronic pain not associated with cancer or HIV. The true number of people who
require pain treatment is much greater. The table only calculates morphine
estimates. Some countries also use methadone or pethidine for pain control. The
table is based on an estimate by Foley and others that 80% of terminal cancer
patients and 50% of terminal AIDS patients will require an average of 90 days
of pain treatment with 60 to 75 mg of morphine per day.[75] Country estimates were obtained from INCB website;[76] projections for annual cancer and AIDS deaths are
based on the most recent cancer and AIDS mortality figures reported by WHO.[77]As the Pain
& Policies Studies Group has pointed out, a population-based method for
estimating the need for controlled medications "will likely overestimate the
quantities that would be consumed when a country lacks the infrastructure and
resources to distribute large quantities of medications."[78]Without such
infrastructure and resources, there is a very real potential that drugs could
be wasted if large quantities are purchased and ultimately not consumed.
Additionally, a potential for diversion exists if large amounts of drugs are
held, unused, in stocks.

INCB has repeatedly reminded countries of their obligation
to submit estimates based upon population need and has encouraged all countries
to review their methods for preparing estimates so as to ensure that they
actually reflect the need for controlled medications.[79]

Ensuring Effective
Distribution

Without an effective distribution system, accessibility of
morphine to those who need it cannot be assured. As controlled medications may
only be transferred between parties that have been authorized under national
law, governments play a key role in putting in place such a distribution
system. They must ensure that a sufficient number of pharmacies are licensed to
handle morphine. They must also ensure that procedures for procuring, stocking
and dispensing it are workable; in other words, they must strike the
appropriate balance between ensuring pharmacies can obtain it without
unnecessarily cumbersome or expensive procedures and preventing abuse.

Yet, in many countries few hospitals or pharmacies actually
stock morphine. In some cases, this is due to government regulations that allow
only specific institutions to stock the medication. The APCA study, for
example, found that in Zambia only hospitals can stock morphine and that in
Nigeria oral morphine is available only from one pharmacy, the National Drug
Store.[80]
Similarly, in Cameroon only one pharmacy prepares oral morphine.[81]

In some countries, excessively burdensome procedures for
procurement, dispensing and accounting discourage health institutions from
procuring morphine. In India, Human Rights Watch found that many hospitals do
not stock oral morphine because they must obtain a number of different licenses
for each order of morphine that is procured and these licenses are often very
difficult to obtain. In Mexico City, a city of 18 million people, only nine
hospitals and pharmacies stock morphine, apparently due to regulatory
requirements around controlled medications.[82] Restrictions on
licenses or cumbersome handling procedures that are not necessary for
preventing abuse of these medications violate the right to health, and should
be reformed. As countries are under the obligation to ensure adequate
availability of opioid analgesics, they must take steps to ensure that a
sufficient number of pharmacies or hospitals stock them. Recognizing this
obligation, Vietnam adopted a new opioid prescription regulation in February
2008 which obliges district hospitals to stock opioids if no pharmacies in the
district do.[83]

Where hospitals and pharmacies do stock morphine, problems
with inefficient distribution systems are common. In India, for example, Human
Rights Watch found that the excessively burdensome procurement procedures in
many states can lead to stock-outs and delays in dispensing.[84]
In Colombia, morphine has regularly been out of stock in the province of Valle
del Cauca over the last several years, resulting in numerous patients being
unable to obtain morphine to treat their pain. By contrast, other prescription
medications have been widely available.[85] APCA's survey of
palliative care providers in twelve African countries found "massive delays
between scripts [physician prescription] and dispensing" due to problems with
supply and distribution systems.[86]

Failure to Enact
Palliative Care and Pain Treatment Policies

A core obligation under the right to health holds that
countries must "adopt and implement a national public health strategy and plan
of action, on the basis of epidemiological evidence, addressing the health
concerns of the whole population." As part of this obligation, countries must
develop a strategy and plan of action for the implementation of palliative care
and pain treatment services. While these do not have to provide for the
immediate implementation of the full range of services, they must set out a
road map for their progressive implementation. There will be a strong
presumption that any cost neutral steps will have to be taken immediately.[87]

In 1996, WHO identified the absence of national policies on
cancer relief pain and palliative care as one of the reasons why cancer pain is
so often not adequately treated.[88]
In 2000, the organization noted that pain treatment continued to be a "low
priority" in healthcare systems. In its 2002 book on cancer control programs,
WHO noted that although governments around the world have endorsed the
integration of palliative care principles into public health and disease
control programs, "a yawning gap is evident between rhetoric and realization."[89]
Two leading experts on palliative care stress the importance of having a
comprehensive strategy, pointing out that some policies have failed because
they omitted community involvement in the provision of palliative care
services.[90]

Yet, as these experts have observed, most countries do not
have palliative care and pain treatment policies, whether as stand-alone
policies or as part of cancer or HIV/AIDS control efforts.[91]
In a 2007 report on palliative care and HIV/AIDS, the UK government's
Department for International Development found that palliative care was often
not "integrated into health sector policies and National AIDS Frameworks."[92]

Many countries have even failed to take relatively
cost-neutral steps that are crucial to improving access to pain treatment and
palliative care, such as adding oral morphine and other opioid-based medicines
to their list of essential medicines or issuing guidelines on pain management
for healthcare workers. For example, respondents to APCA's 2007 survey of
palliative care providers from four countries-Kenya, Namibia, Nigeria and
Rwanda-reported that oral morphine was not on their country's list of essential
medicines.[93]
According to Anne Merriman, a leading palliative care advocate in Africa, only
fourteen African nations have oral morphine-all others only have injectable
morphine, which is primarily used to treat acute pain in hospital settings.[94]

INCB has recommended that national drug control laws must
recognize the indispensible nature of narcotic drugs for the relief of pain and
suffering as well as the obligation to ensure their availability for medical
purposes. Its 1995 survey found that the laws of 48 percent of responding
governments contained the former and of 63 percent the latter.[95]
Although it is not known exactly how many countries still do not have the
relevant language in their legislation, it is telling that the model laws and
regulations on drug control that the UN Office on Drugs and Crime has developed
for the use of countries in developing national drug control laws and
regulations themselves do not contain these provisions.[96] A
new draft drug control law that is currently under consideration in Cambodia
makes no reference to the fact that controlled medications are indispensible
for the relief of pain and suffering or of the obligation to ensure their
availability.[97]

Lack of Training for Healthcare
Workers

One of the biggest obstacles to provision of good palliative
and pain treatment services in many countries around the world is a lack of
training for healthcare workers. As Brennan and others put it, "for too long,
pain and its management have been prisoners of myth, irrationality, and
cultural bias."[98]
While misinformation about oral morphine remains extremely common among
healthcare workers, knowledge about how to assess and treat pain is often
absent or deeply inadequate. The combination of ignorance among healthcare
workers with myths about opioids results in failure to treat patients, who are
suffering from severe pain, with opioid analgesics.

Some of the most common myths hold that treatment with
opioids leads to addiction-the most frequently cited impediment to the medical
use of opioids in INCB 1995 study;[99]
that pain is necessary; that it is essential for diagnosis; that it is
unavoidable; and that it has negligible consequences. Each of these myths is
inaccurate.[100]
Numerous studies have shown that treatment of pain with opioids very rarely
leads to addiction;[101]
most pain can be treated well;[102]
pain is not necessary for diagnosis;[103] and pain has
considerable social, economic and psychological consequences as it keeps people
who suffer from pain and often their caregivers out of productive life.[104]

Ignorance about the use of opioid medications is the result
of a failure, across much of the world including in some industrialized
countries, to provide healthcare workers with adequate instruction on
palliative care and pain management. A survey by the Worldwide Palliative Care
Alliance among healthcare workers in 69 countries in Africa, Asia and Latin
America found that 82 percent of healthcare workers in Latin America and 71
percent in Asia had not received any instruction on pain or opioids in
undergraduate medical studies. In Africa, the figure was 39 percent.[105]
In a 2007 African Palliative Care Association survey, 33 out of 56
participating healthcare providers felt that there were insufficient training
opportunities on palliative care and pain treatment. Twenty-one of the
twenty-three providers that said that there was adequate opportunity for
training were based in South Africa and Uganda, two countries where
considerable training is available.[106]

Under the right to health, governments must take reasonable
steps to ensure healthcare workers have appropriate training on palliative care
and pain management. As an integral part of care and treatment for cancer and
HIV, two key diseases around the world, countries need to ensure that basic
instruction on palliative and pain management is part of undergraduate medical
studies, nursing school, and continuing medical education. Specialized
instruction should be available for healthcare workers who pursue a
specialization in oncology, HIV and AIDS and other disciplines where knowledge
of pain management and palliative care is an integral part of care.

The 1961 Single Convention on Narcotic Drugs lays out three
minimum criteria that countries must observe in developing national regulations
regarding the handling of opioids:

·Individuals must be authorized to dispense
opioids by their professional license to practice, or be specially licensed to
do so;

·Movement of opioids may occur only between
institutions or individuals so authorized under national law;

·A medical prescription is required before
opioids may be dispensed to a patient.

Governments may, under the Convention, impose additional
requirements if deemed necessary, such as requiring that all prescription be
written on official forms provided by the government or authorized professional
associations.[108]

However, as WHO has observed, "this right must be
continually balanced against the responsibility to ensure opioid availability
for medical purposes."[109]
Therefore, any regulations that unnecessarily impede access to controlled medications
will be inconsistent with both the UN drug conventions and the right to health,
which requires countries find a similar balance between ensuring availability
for legitimate medical use and preventing abuse. WHO has developed guidelines
for the regulation of health professionals who handle controlled medications
that government can use to develop what WHO has called a "practical system."[110]

Yet, many countries have regulations that are unnecessarily
strict, creating complex procedures for procurement, stocking and dispensing of
controlled medications. In some cases, drug control authorities or health
systems go even beyond the strictures of regulations in their implementation
and which limit access to those who need them. The effect of these unnecessarily
strict regulations or implementation practices is that pharmacies and health
facilities do not procure and stock opioids, that doctors do not prescribe them
because of the hassle or fear of criminal sanction, and that prescription is so
impractical that many patients cannot realistically obtain them on an ongoing
basis.

One explanation for the existence of excessively strict
regulations is the fact that many of these regulations were put in place before
1986, when WHO first recommended the use of oral morphine for long-term pain
management.[111]
Before that, most countries used only injectable morphine to treat acute pain,
which is mostly used in hospital settings over short periods of time. As WHO
has noted, "The science and best practices of opioids have progressed more
rapidly than the legal structures governing them, leaving many antiquated and
overly restrictive legal policies."[112]

Since the 1980s, WHO and INCB have repeatedly called on
countries to review their drug control regulations and implementation
practices, and make sure they do not unnecessarily impede the use of oral
morphine. While INCB has repeatedly reminded states that they must continue to
take steps to prevent diversion[113]-controlled
medications being diverted for illicit use-it has also noted that:

Diversion of narcotic drugs from the licit trade into
illicit channels remains relatively rare and the quantities involved are small
in comparison to the large volume of transactions. That holds true for drugs in
the international trade as well as in domestic wholesale circuits.[114]

Some countries have taken important steps in this regard.
Uganda, for example, has approved nurse-based prescribing of oral morphine.
Several countries have lifted restrictions on the amount of oral morphine that
can be prescribed. Yet, in many countries problematic regulations continue to
be in place. A number of common problems in these regulations include:

Overly Restrictive
Licensing of Healthcare Institutions

Some countries impose licensing procedures for pharmacies
and healthcare providers that make it impossible or overly complicated for them
to procure and dispense opioids. Palliative care providers that do not have
inpatient facilities but offer home-based care services often have a particular
difficulty getting licenses to dispense morphine, even though this is vital to
their mission and they can provide a low-cost way of reaching large numbers of
people in need of pain treatment. In its 2007 report, the African Palliative
Care Association observed for example that:

Although in theory many countries permit importation and
distribution of the drugs, it can be impossible in practice to obtain the
necessary authority from regulation bodies to prescribe the drugs.[115]

Palliative care providers in Kenya surveyed by APCA noted,
for example, that oral morphine is "mostly dispensed in hospitals and hospices
so many patients [who are not in such institutions] do not get access."[116]
A 2007 report by the Worldwide Palliative Care Alliance quotes a healthcare
worker as saying that

Palliative care doctors have a right to prescribe morphine
but cannot obtain it if they work in a hospice which is not registered in the
Ministry of Health as a medical organization.[117]

In India, regulations in some states make it practically
impossible for palliative care providers to obtain a license to prescribe oral
morphine, while in other states regulations establish a straight- forward
procedure that has allowed palliative care providers to play a key role in
making pain treatment available at the community level.[118]

Some countries allow only certain types of medical
institutions to prescribe opioids. For example, in China, only hospitals above
Level 2-hospitals in China are ranked from Level 1 to 3 depending on the
jurisdiction they fall under-have the right to prescribe opioids, which means
that hospitals in many cities and towns cannot dispense opioids and people may
have to travel long distances in order to be able to obtain oral morphine.[119]

These licensing requirements significantly impede access to
oral morphine. Countries need to ensure that all healthcare providers and
pharmacies are either automatically licensed to procure, stock, and dispense by
virtue of their registration as a healthcare institution, or have access to a
rational and transparent procedure for obtaining a special license. There is no
rational reason for denying palliative care programs that provide mostly
home-based care services the right to prescribe and dispense oral morphine.

Licensing of Health
Workers

Many countries require special licenses for healthcare
workers who want to prescribe opioids, and these licenses are often difficult
to obtain. For example, the Worldwide Palliative Care Alliance reported in its
2007 report that in Mongolia, Peru, Honduras, Kyrgyzstan and a state in India
only palliative care specialists and oncologists are authorized to prescribe
oral morphine; that in the Philippines doctors must obtain two special licenses
to be able to prescribe; and found that seventeen percent of locations (countries
and sub-national regions) covered by the survey required special licenses that
were hard to obtain.[120]
At the 2008 Eastern European and Central Asian AIDS Conference, a Russian AIDS
doctor told conference delegates that he could not treat a patient who suffered
from severe pain because he was not licensed to prescribe morphine and that
oncologists, who are, would not be able to provide her with morphine because
she was not a cancer patient.[121]

While medical doctors in many countries can prescribe
morphine by virtue of their professional license, this is not the case for
nurses. This is a considerable problem in many middle and low income countries
around the world where there are few medical doctors. For example, in Malawi
there is only one doctor per 100,000 people.[122] In 2004, Uganda
introduced nurse-based prescribing of oral morphine. According to its amended
regulations nurses with a certificate in specialized palliative care are
permitted to prescribe and supply certain types of opioid analgesics, including
oral morphine.[123]
Prior to 2004, many people in rural Uganda-where there is one physician per
50,000 people-did not have realistic access to medications for moderate to
severe pain. INCB praised Uganda for this important step.[124]

Under the 1961 Single Convention on Narcotic Drugs, states
do not have to require that healthcare workers obtain a special license to
handle opioids. WHO has recommended that "physicians, nurses and pharmacists
should be legally empowered to prescribe, dispense and administer opioids to
patients in accordance with local needs."[125] As special
licensing procedures impede accessibility of opioids for patients who need
them, countries should strive as much as possible to allow healthcare workers
to handle opioids by virtue of their professional license or establish rapid
rational and transparent procedures for obtaining special licenses.

Burdensome Prescription
Procedures

Some countries have established special prescription
procedures for opioids that are cumbersome and discourage healthcare workers
from prescribing them. A common example is the requirement to use special
prescription forms and to keep multiple copies of the prescription. The WHO
Expert Committee on Cancer Pain Relief and Active Support Care has observed
that special multiple-copy prescription requirements "typically…reduce
prescribing of covered drugs by 50 percent or more."[126]
Yet, countries ranging from Cote d'Ivoire to Ukraine require such special
prescription forms.[127]
In 1995, INCB found that 65 percent of countries that participated in its
survey had special prescription procedures.[128]

Another common problem is that prescriptions by healthcare
workers must be approved by their colleagues or superiors or that dispensing
must be witnessed by multiple healthcare workers. In Ukraine, for example,
decisions to prescribe morphine have to be made by a group of at least three
doctors, one of whom must be an oncologist.[129] In South Africa,
two nurses must observe the dispensing of opioids.[130]
In Guatemala, every prescription must be authorized through an ink seal and a
signature that are only issued in the central office of the Narcotic Control
Agency.[131]
In Colombia, the National Fund follows up every prescription with phone calls
to the prescribing doctor.[132]
In Vietnam, some hospitals mandate that all doctors and nurses return empty
morphine ampoules to the chief pharmacist or otherwise be investigated for
opioid diversion, even though Vietnam's drug control regulations do not so
require.[133]

Many of these special prescription procedures go well beyond
what is required by the 1961 Single Convention and are unlikely to be necessary
for preventing diversion. WHO has recommended that "if physicians are required
to keep records other than those associated with good medical practice, the
extra work incurred should be practicable and should not impede medical
activities."[134]
Requirements that do not need meet those criteria will violate the right to
health.

Prescription
Limitations

Regulations in some countries impose limitations on the dose
of oral morphine that can be prescribed per day or unnecessarily restrict the
number of days that it can be prescribed and dispensed for at once. These
restrictions impede access to adequate pain management. WHO has recommended
that "decisions concerning the type of drug to be used, the amount of the
prescription and the duration of therapy are best made by medical professionals
on the basis of the individual needs of each patient, not by regulation."[135]

The 1995 INCB survey found that 40 percent of countries participating
set a maximum amount of morphine that could be prescribed at one time to a
hospitalized patient, and 50 percent did so for patients who lived at home.[136]
INCB noted that some governments had set the maximum amount "as low as 30
milligrams" – or approximately half the average daily dose in low and middle
income countries.[137]
WPCA reported in 2007 that Israel limits morphine prescription to 60 milligrams
per day for non-cancer patients.[138]
It is unclear how many other countries maintain dosage limitations today.
Dosage limitations make no medical sense as patient need varies considerably
from person to person, and some people require very large doses to achieve
adequate pain control. They are therefore not consistent with the right to
health.

The 1995 INCB report found that 20 percent of countries
participating in the survey imposed a maximum length of time that a
hospitalized patient could receive morphine, and 28 percent of governments had
such restrictions for patients at home. In some cases, patients could only
receive morphine for three to seven days at once and sometimes that was not
renewable.[139]
Although no comprehensive overview of countries that impose these kinds of
limitations today is available, they continue to be widespread. WPCA reported
in 2007 that Honduras and Malawi do not allow morphine to be dispensed for more
than three days at a time.[140]
In China, prescriptions can only be given for seven days at a time.[141]
In Israel, prescriptions can only be given for ten days at a time unless the
doctor confirms that the patient lives far away from a pharmacy.[142]

While there are good reasons, including preventing
diversion, for certain limitations on the length of time medications can be
dispensed, the kinds of restrictions mentioned above make it impractical or
impossible for many patients to have continuous access to them. Many patients
live far away from pharmacies or healthcare centers and repeated travel is a
considerable burden because of expense and difficulty of travel for people who
are ill. It also puts a drain on healthcare workers who are already overworked
in many parts of the world. Any limitations on the amount of time morphine can
be described or dispensed for should be reasonable-the limitations should be
necessary for preventing abuse and not result in the medication becoming
practically inaccessible for people who need them-otherwise they will violate
the right to health. In recent years, an increasing number of countries have
relaxed the length of time for which oral morphine can be prescribed at once,
with many settling on about a month. These countries include Romania (from 3 to
30 days), France (from 7 to 28 days), Mexico (from 5 to 30 days), Peru (from 1
to 14 days), and Colombia (from 10 to 30 days).[143]

Fears of Legal Sanction

In some countries, a key reason for the low consumption of
opioid medications is fear among healthcare workers that they may face legal
sanctions for prescribing them. INCB has recommended that

health professionals…should be able to…[provide
opiates]…without unnecessary fear of sanctions for unintended violations
[including]…legal action for technical violations of the law…[that]…may tend to
inhibit prescribing or dispensing of opiates.[144]

Almost fifty percent of countries participating in the 1995
INCB survey cited such fear as an impediment to medical use of opioids.[145]
In APCA's survey of national drug control authorities, four out of five cited
fears among healthcare professionals as one of the key reasons for low use of
opioid medications. The drug control authority in Kenya stated that "due to the
punitive nature of the 1994 Act, most providers have shied away from selling
opioids."[146]

Ambiguity in regulations, poor communication by drug
regulators to healthcare workers about the rules for handling opioids, the existence
of harsh sanctions are some of the reasons for this persistent fear among
medical professionals, and, in some countries, actual prosecutions of
healthcare workers for unintentional mishandling of opioids. In China, for
example, regulations that were adopted in 2005-and have significantly improved
accessibility of opioids-hold that healthcare workers can prescribe opioids for
"reasonable need" but the rules do not clearly define reasonable.[147]
In INCB's 1995 survey some countries reported that failure to comply with laws
and regulations governing opiate prescribing could result in a 22-year prison
sentence. Almost fifty percent of participating countries reported mandatory
minimum sentences, some as high as 10 years in prison.[148]
In some cases, these are sentences for unintentional mistakes in handling
opioids, not for drug dealing.

In the United States, many physicians are reported to fear
unjustified prosecution or sanctioning for prescribing opioids for pain and,
consequently, tend to under-prescribe.[149] While a recent
survey of criminal and administrative cases between 1998 and 2006 found that
the number cases had grown from 17 in 1998 to 147 in 2006, the study also
concluded that "the widely publicized chilling effect of physician prosecution
on physicians concerned with legal scrutiny over prescribing opioids appears
disproportionate to the relatively few cases in which convictions and
regulatory actions have occurred."[150]
The authors suggested that

[I]t seems likely that physicians react to frightening or
inconsistent public policy statements. Likewise, they are sensitive to
experience with, or lore about, investigations that were ultimately dismissed
but which disrupted a medical practice and produced fear and possibly panic.
Thus, the chilling effect may be, in part, related to public relations and
communications problems on the part of regulators as well as to how law
enforcement handles the full number of its investigations, not just those that
lead to conviction or discipline. Thus, these data may be extrapolated to
suggest that regulators and law enforcement may do well to improve how they
craft their public messages to physicians and how they handle routine
investigations of medical practice. These phenomena deserve greater study.[151]

Unfortunately, the U.S. Drug Enforcement Administration's
public message to physicians who prescribe opioids has been ambiguous. After
initially supporting a series of Frequently Asked Questions (FAQ) for
physicians about the use of pain management medications that had been developed
by a panel of clinicians and regulators, including DEA officials, it abruptly
pulled the FAQ from its website in August 2004, creating confusion over what
acceptable prescribing practices are.[152] It has not been
re-posted since.

While countries have a right-and an obligation under the
drug conventions-to take legal action against medical professionals who
dispense opioids for non-medical uses, criminalizing unintentional mistakes in
opioid prescription is not consistent with the right to health. Furthermore,
countries must ensure that regulations are unambiguous and that complete
information about them is readily available for healthcare providers.

Cost

Cost is a frequently cited impediment to improving access to
pain treatment and palliative care services, particularly for low and middle
income countries. Under the right to health, governments do not have to offer
medications such as oral morphine free of charge. However, they must strive to
ensure that they are "affordable to all." In some countries and for certain
sections of countries' populations that will mean that it must be provided at
no or very little charge. In any case, governments must take all reasonable
efforts to ensure that medications are available at a reasonable price that is
affordable for patients.

Basic oral morphine should be very cheap. Cipla in India
makes 10 mg morphine tablets that sell at US$0.017 cents each.[153]
Foley and others estimate that generic morphine should not cost more than
US$0.01 per milligram.[154]
An average month's supply of morphine would cost US$9 to 22.5 per month per
patient.[155]

In reality, however, morphine is often much more expensive.
A study by De Lima and others found that the average retail cost of a monthly
morphine supply in 2003 ranged from US$10 in India to US$254 in Argentina. The
study found that median cost of a month's supply of morphine was more than
twice as high in low and middle income countries (US$112) as in industrialized
countries (US$53).[156]
The study suggested that a number of factors might explain the discrepancy: the
fact that most industrialized countries subsidized medications while low and
middle income countries did not; that several industrialized governments
regulated the price of opioids; taxes, licenses and other costs related to
import of finished product; large overhead of local production; poorly
developed distribution systems; low demand; and regulatory requirements that
drive up cost.[157]

A 2007 report of the W0rldwide Palliative Care Alliance also
found that the promotion of non-generic-and costly-forms of opioid analgesics
has made pain treatment medications unaffordable in some areas. It stated that
"when expensive formulations of opioids appear on the market, inexpensive
immediate-release morphine often becomes unavailable" as pharmaceutical
companies withdraw basic oral morphine from the market. It cited India as an
example of a country where in some places hospitals have costly sustained
release morphine or transdermal fentanyl but no immediate release morphine,
even though the regulatory barriers are the same for both.[158]

Governments have an obligation to explore ways to ensure
that basic morphine is available at low cost to people who are in need of pain
treatment. A number of countries have successfully sought ways to create
capacity for local production of basic oral morphine, in tablet or liquid form,
at low cost. For example, in the state of Kerala in India, a small
manufacturing unit has been set up at a hospital that produces low cost
immediate release morphine tablets from morphine powder that is purchased from
a factory at Ghazipur.[159]
In Uganda, the ministry of health commissioned charitable procurement and
manufacturing facility to produce morphine solution which could be distributed
to hospitals, health centers and palliative care providers. Before deciding on
this option, the ministry of health had approached commercial manufacturers but
these were not interested in producing morphine solution due to lack of
profitability.[160]
In Vietnam, a new opioid prescription regulation allows the ministry of health
to mandate state and para-state pharmaceutical companies to produce oral and
injectible opioids.[161]

Breaking Out of the
Vicious Cycle of Under-Treatment

Comprehensive steps to address all barriers simultaneously
are needed in countries where a vicious cycle of under-treatment exists.
Governments have the responsibility to lead this process. They need to develop
plans for the implementation of palliative care and pain treatment, adopt
relevant policies, introduce instruction for healthcare workers, and ensure
adequate availability of morphine and other opioid medications. The WHO, INCB,
and donor community must assist in these efforts.

A number of countries have begun such efforts, with some
success. Uganda and Vietnam with the support of the international community,
have made important progress in improving pain treatment and palliative care
services for the population.[162]
But both still have a long way to go. Morphine consumption in both continues to
be low, certain regulatory barriers remain, and large numbers of people
suffering from moderate to severe pain still do not have access to adequate
treatment. But the steps these countries have taken are laying the foundation
for replacing the vicious cycle of under-treatment of pain with a positive
cycle in which simpler drug control regulations and better knowledge among
healthcare providers leads to increased demand for morphine, reinforcing the
importance of pain management and palliative care and leading to greater awareness
among healthcare workers and the public.

Uganda

Uganda, an East African country of about 31 million, has
made considerable progress in tearing down barriers that have traditionally
impeded the ability of people to access pain treatment medications. In 1998,
Ugandan government officials, representatives of non-governmental
organizations, and WHO sat down together at a conference entitled "Freedom from
Cancer and AIDS Pain" to discuss ways in which pain treatment could be made
available to the population. At the meeting, participants agreed to take a
series of simultaneous steps to deal with key barriers:

The Ministry of Health and WHO were to develop a national
palliative care policy, and cancer and AIDS pain relief policies.

Although Hospice Africa Uganda had taught palliative
medicine in the medical, nursing and pharmacy schools and to practicing
post graduate health professionals since 1993, the Government initiated
meetings which resulted in the endorsement of a 9-month full time course
training at Hospice Africa Uganda, to increase the number of prescribers.

The drug control authority was to develop new drug
regulations, update the essential drug list, conduct estimates of the
medical need for morphine, and request an increased national allowance
from INCB.

In addition, a commitment was made to ensure coordination of
palliative care activities for AIDS and cancer, to set up multidisciplinary
clinics for cancer patients, to increase awareness of palliative care among the
population, and to identify a demonstration project in Uganda's Hoima District
where Little Hospice Hoima, a branch of Hospice Africa Uganda was already
active.[163]

In its five-year Strategic Health Plan for 2000-2005, the
governmentstated that palliative care was an essential clinical service for all
Ugandans, becoming the first nation in Africa to do so. It also added liquid
morphine to its essential drug list, adopted a new set of Guidelines for
Handling of Class A Drugs for healthcare practitioners-also a first in
Africa-and, in 2003, authorized prescribing of morphine by nurses who have been
trained in palliative care.

By early 2009, 79 nurses and clinical officers had received
training on pain management and been authorized to prescribe oral morphine;
several thousand healthcare workers had attended a short course on pain and
symptom management; and 34 out of 56 districts in Uganda had oral morphine
available and in use. Despite this impressive progress, many challenges remain,
including ensuring availability of oral morphine throughout Uganda; keeping it
affordable; preventing stock-outs; and training all relevant healthcare
workers.[164]

Vietnam

Since 2005, Vietnam, a country of 84 million people, has
made considerable progress in expanding access to palliative and pain treatment
services. This progress started with the creation of a working group on
palliative care. This working group, which consisted of ministry of health
officials, cancer and infectious disease physicians, and experts from NGOs
supported by the US President's Emergency Plan for AIDS Relief, decided to
conduct a rapid situation analysis to assess the availability of and the need
for palliative care in Vietnam, and to subsequently develop a national
palliative care program based on its findings.

The rapid situation analysis found, among others, that:

·Severe chronic pain was common among cancer
and HIV/AIDS patients;

·Availability of opioid analgesics and other
key medications was severely limited;

·Palliative care services were not readily
available to the population; and

Based on these finding, the working group recommended that
national palliative care guidelines be developed, a balanced national opioid
control policy be developed, training for healthcare workers be expanded, and
that availability and quality of palliative care services be improved at all
levels.

In September 2006, the ministry of health issued detailed
Guidelines on Palliative Care for Cancer and AIDS Patients, which provide
guidance to practitioners on palliative care and pain management. In February
2008, it issued new guidelines on opioid prescription which have eased a number
of key regulatory barriers. For example, the maximum daily dose has been
abolished; prescriptions can now be issued for 30 days, rather than 7;[166]
and district hospitals and commune health posts are now authorized to prescribe
and dispense. The ministry has also approved a package of training courses for
practicing physicians and two medical colleges now offer instruction on
palliative care to undergraduate medical and nursing students.

Yet, numerous challenges remain as only a few hundred
healthcare workers have received training so far, understanding of palliative
care among healthcare officials continues to be limited, various regulatory
barriers persist,[167]
and few pharmacies and hospitals stock oral morphine.

Recommendations

The pain treatment gap is an international human rights
crisis that needs to be addressed urgently both at the international and
national level. Therefore, Human Rights Watch makes the following
recommendations:

To governments around
the world

General

·Establish, where this has not yet been done,
a working group on palliative care and pain management. This working group
should include all relevant actors, including health officials, drug
regulators, healthcare providers, nongovernmental palliative care providers,
and academics, and develop a concrete plan of action for the progressive
implementation of pain treatment and palliative care services.

·Assess both the availability of and the need
for pain management and palliative care services.

·Develop a comprehensive plan of action that
addresses the various barriers that impede availability of pain management and
palliative care, including government policy, education, and availability of
medications.

·Invite the WHO Access to Controlled
Medications Programme to assist them in implementing the above recommendations.

·National human rights commissions or
ombudsman offices should, where possible, investigate obstacles to availability
of pain management and palliative care services, and request that their
governments take urgent measures to address them.

Ensuring an Effective
Supply System

·Submit, in a timely fashion, realistic
estimates for the need of controlled medications to the INCB.

·Ensure an effective distribution system for
controlled medications. While procurement, transportation and stocking
regulations should be able to prevent potential abuse, they should not
arbitrarily complicate these processes.

·Countries must ensure that in each region at
least a minimum number of pharmacies and hospitals stock morphine.

·Include oral morphine and other essential
pain treatment medications in national lists of essential medicines;

·Ensure that drug control laws and
regulations recognize the indispensible nature of opioid and other controlled
medications for the relief of pain and suffering, as well as the obligation to
ensure their adequate availability;

Ensuring Instruction
for Healthcare Workers

·Ensure adequate instruction for healthcare
workers, including doctors, nurses, and pharmacists, at both undergraduate and
postgraduate level.

· Instruction should also be offered to those
already practicing as part of continuing medical education.

Reforming Drug
Regulations

·Review drug control regulations to assess
whether they unnecessarily impede accessibility of pain medications. Healthcare
providers should participate in conducting this review.

·If regulations are found to impede access,
they should be amended. Recommendations of WHO and healthcare providers should
lay at the foundation of revised drug control regulations.

·Requiring special licenses for healthcare
institutions or providers to handle morphine should be avoided as much as
possible. In other cases, transparent and simple procedures should be
established for obtaining such special licenses.

·Special prescription procedures for
controlled medications should be avoided as much as possible. Where they are
nonetheless in place, they should be minimally burdensome.

·Limitations on the amount of morphine that
can be prescribed per day should be abolished.

·Unnecessary limitations on the amount of
morphine that can be prescribed or dispensed at once should be abolished.

Ensuring Affordability
of Medications

·Countries should seek to ensure the
affordability of morphine and other opioid analgesics.

To global drug policy
makers

·Restore the balance between ensuring
availability of controlled medications and preventing abuse, as provided for by
the UN drug control conventions, in global drug policy debates. Access to
controlled medications should be a central and recurring agenda item at the
Commission on Narcotic Drugs and other meetings on global drug policy.

·At the UN General Assembly Special Session
on Drugs in March 2009, countries should make improving availability of pain
treatment medicines, and controlled medications generally, a priority. They
should set ambitious and measurable goals to significantly improve access to
these medicines worldwide over the coming ten years.

·After March 2009, relevant international
agencies, such as the Commission on Narcotic Drugs and INCB, should regularly
review progress made by countries toward adequate availability of pain
treatment medications, carefully analyzing steps taken to advance this
important issue.

·INCB should significantly increase its
efforts to encourage and assist states in improving availability of opioid analgesics.

·UNODC should amend the model laws and
regulations it has developed to include recognition of the indispensible nature
of narcotic drugs and psychotropic substances for medical and scientific
purposes, and the obligation for states to ensure their availability.

To WHO, UNAIDS, and the
donor community

·WHO should continue to treat access to
controlled medications with urgency through its Access to Controlled
Medications Programme.

·Donor countries and agencies, including the
Global Fund to fight AIDS, Malaria, and Tuberculosis and the U.S. President's
Emergency Plan for AIDS Relief, should actively encourage countries to
undertake comprehensive steps to improve access to pain relief medications and
support those that do, including through support for the WHO Access to
Controlled Medications Programme.

·UNAIDS should work with governments to
identify and remove obstacles to availability and accessibility of pain
management and palliative care services.

To the global human
rights community

·UN and regional human rights bodies should
routinely remind countries of their obligation under human rights law to ensure
adequate availability of pain medications.

·Human rights groups should include access to
pain treatment and palliative care into their work, including by submitting
shadow reports to UN treaty bodies, providing information to the UN Special
Rapporteurs on the Highest Attainable Level of Health and on Torture, Cruel,
Inhuman and Degrading Treatment and Punishment, to the Human Rights Council.

Acknowledgements

This report was researched and written by Diederik Lohman,
senior researcher in the Health and Human Rights division of Human Rights
Watch. It was edited by Joseph Amon, director of the Health and Human Rights
division; and reviewed by Rebecca Schleifer, advocate in the Health and Human
Rights division; Clive Baldwin, senior legal advisor at Human Rights Watch; and
Iain Levine, program director at Human Rights Watch. Relevant sections were
reviewed by Maria Burnett, researcher in the Africa division; Sara Colm, senior
researcher in the Asia division and David Fathi, director of the US program at
Human Rights Watch. Seth Davis, Olena Baev and Emily Dauria, interns in the
Health and Human Rights division, provided invaluable research assistance. Production
assistance was provided by Mignon Lamia, Grace Choi, Anna Lopriore, and Fitzroy
Hepkins.Human Rights Watch is deeply grateful to the numerous pain
treatment and palliative care experts who assisted us in preparing this report.

[1] Human Rights Watch
interview, Kerala, India, March 20, 2008. The name of the patient is withheld
for reasons of privacy.

[2] The ad appeared in
the newspaper El Pais in Cali, Colombia, on September 12, 2008.

[24] Kathleen M.
Foley, et al., "Pain Control for People with Cancer and AIDS."

[25] Ibid. This is an
estimate for low and middle income countries. The average daily dose in
industrialized countries tends to be higher. This is due, among others, to
longer survival of patients and the development among patients of tolerance to
opioid analgesics. Email communication with Kathleen M. Foley, January 23,
2009.

[30] Cited in WHO, Achieving
Balance in National Opioids Control Policy, p. 3.

[31] While there is increasing
acceptance of the need for palliative care and pain treatment services for
cancer patients, the focus on ensuring antiretroviral treatment to people
living with HIV has detracted attention from palliative care needs of this
group. In a March 2007 report, DFID noted that"dominant global and national
policy on increasing access to treatment, and progress made in expanding access
to ARVs, has added to the perception that palliative care is increasingly
irrelevant. This is contrary to clinical evidence of the need for palliative
care alongside treatment…. Not only do people on ARVs often need palliative
care services, millions of people continue to die of AIDS and many could
benefit from palliative care and pain treatment services." DFiD Health Resource
Center, "Review of global policy architecture and country level practrice on
HIV/AIDS and palliative care," March 2007, p. 16.

[32] Preamble of the
1961 Single Convention on Narcotic Drugs, http://www.incb.org/incb/convention_1961.html
(accessed January 15, 2009).

[33] INCB, "Availability
of Opiates for Medical Needs: Report of the International Narcotics Control
Board for 1995," http://www.incb.org/pdf/e/ar/1995/suppl1en.pdf (accessed
January 15, 2009), p.1.

[48] INCB, "Report of
the International Narcotics Control Board for 2004," United Nations,
E/INCB/2004/1, 2005; INCB, "Use of essential narcotic drugs to treat pain is
inadequate, especially in developing countries,"press Release, March 3, 2004.

[56] UN UN Committee
on Economic, Social and Cultural Rights, "Substantive Issues Arising in the
Implementation of the International Covenant on Economic, Social and Cultural
Rights," General Comment No. 14, The Right to the Highest Attainable Standard
of Health, E/C.12/2000/4 (2000),http://www.unhchr.ch/tbs/doc.nsf/(Symbol)/40d009901358b0e2c1256915005090be?Opendocument
(accessed May 11, 2006), para. 43. The Committee on Economic, Social and
Cultural Rights is the UN body responsible for monitoring compliance with the
International Covenant on Economic, Social and Cultural Rights.

[62] International
Covenant on Civil and Political Rights (ICCPR), adopted December 16, 1966, G.A.
Res. 2200A (XXI), 21 U.N. GAOR Supp. (No. 16) at 52, U.N. Doc. A/6316 (1966),
999 U.N.T.S. 171, entered into force March 23, 1976, art. 7 provides, "No one
shall be subjected to torture or to cruel, inhuman or degrading treatment or
punishment"; Universal Declaration of Human Rights (UDHR), adopted
December 10, 1948, G.A. Res. 217A(III), U.N. Doc. A/810 at 71 (1948);
Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or
Punishment (Convention against Torture), adopted December 10, 1984, G.A. res.
39/46, annex, 39 U.N. GAOR Supp. (No. 51) at 197, U.N. Doc. A/39/51 (1984),
entered into force June 26, 1987, article 16 provides that "Each State Party
shall undertake to prevent in any territory under its jurisdiction other acts
of cruel, inhuman or degrading treatment or punishment which do not amount to
torture as defined in article I, when such acts are committed by or at the
instigation of or with the consent or acquiescence of a public official or
other person acting in an official capacity"; Inter-American Convention to
Prevent and Punish Torture, O.A.S. Treaty Series No. 67, entered into force
February 28, 1987; European Convention for the Prevention of Torture and
Inhuman or Degrading Treatment or Punishment (ECPT), signed November 26, 1987,
E.T.S. 126, entered into force February 1, 1989; African [Banjul] Charter on
Human and Peoples' Rights, adopted June 27, 1981, OAU Doc. CAB/LEG/67/3 rev. 5,
21 I.L.M. 58 (1982), entered into force October 21, 1986.

[63]
See for example the judgment of the European Court of Rights in Z v United
Kingdom (2001) 34 EHRR 97.

[64] A copy of the
letter is available at http://www.ihra.net/Assets/1384/1/SpecialRapporteursLettertoCND012009.pdf
(accessed January 16, 2009).

[65] See for example, INCB,
"Availability of Opiates for Medical Needs: Report of the International
Narcotics Control Board for 1995," p. 1,
http://www.incb.org/pdf/e/ar/1995/suppl1en.pdf (accessed January 15, 2009);
INCB, "Report of the International Narcotics Control Board for1999"; INCB, "Report
of the International Narcotics Control Board for 2007," http://www.incb.org/incb/en/annual-report-2007.html;
WHO, "Achieving Balance in National Opioids Control Policy"; ECOSOC resolution
2005/25 on Treatment of pain using opioid analgesics (36th plenary meeting 22
July 2005),
http://www.un.org/docs/ecosoc/documents/2005/resolutions/Resolution%202005-25.pdf
(accessed January 16, 2009); World Health Assembly, Resolution WHA 58.22 on
Cancer prevention and control (Ninth plenary meeting, 25 May 2005 – Committee
B, third report), http://www.who.int/gb/ebwha/pdf_files/WHA58/WHA58_22-en.pdf
(accessed February 2009).

[66] INCB, "Report of
the International Narcotics Control Board for 2007," para. 97.

[67] INCB, "Availability
of Opiates for Medical Needs: Report of the International Narcotics Control
Board for 1995,"p.
14.

[72] Country estimates
for 2009 can be found on the INCB website, http://www.incb.org/pdf/e/estim/2009/Est09.pdf
(accessed January 13, 2009).

[73] Under the UN drug
conventions, countries can request additional quota from INCB if the requested
quota turns out to be insufficient. But countries that have poor systems for
estimating their need are unlikely to submit supplementary requests.

[74] For example,
Algeria, Iran, Namibia, and Thailand have all submitted the same round-number
estimate for the last four years.

[75] Kathleen M.
Foley, et al.,"Pain Control for People with Cancer and AIDS."

[76] Available at http://www.incb.org/incb/narcotic_drugs_estimates.html
(accessed January 22, 2009).

[79] INCB, "Availability
of Opiates for Medical Needs: Report of the International Narcotics Control
Board for 1995," p. 8.

[80] Harding R, et
al., "Pain Relieving Drugs in 12 African PEPFAR Countries,"pp. 21 and
27. Since the APCA report was published, the National Agency for Food and Drug
Administration Control has drawn up and approved a plan to decentralize
national drug stores, which will eventually ensure availability of morphine
outside Lagos.

[81] Email
correspondence with Anne Merriman of Hospice Uganda and a leading palliative
care doctor and advocate in Africa, January 24, 2009.

[82]Email
correspondence with Liliana de Lima, Executive Director of the International
Hospice and Palliative Care Association, February 11, 2009.

[83] Email
communication with Kimberly Green of Family Health International Vietnam,
January 25, 2009.

[84]
In many states in India, healthcare institutions and morphine manufacturers
must obtain five licenses from several different government offices in both the
importing and exporting state before they can procure morphine-a process that
can take months.

[95] INCB, "Availability
of Opiates for Medical Needs: Report of the International Narcotics Control
Board for 1995," p. 5.

[96] See the Model Law
on the Classification of Narcotic Drugs, Psychotropic Substances and Precursors
and on the Regulation of the Licit Cultivation, Production, Manufacture and
Trading of Drugs; the Model Regulation Establishing an Interministerial
Commission for the Coordination of Drug Control; and the Model Drug Abuse Bill,
http://www.unodc.org/unodc/en/legal-tools/Model.html (accessed January 24,
2009); A detailed analysis of provisions regarding controlled medications in
the model laws and regulations can be found in a January 2009 report by the
Pain & Policy Studies Group, entitled "Do International Model Drug Control
Laws Provide for Drug Availability?" http://www.painpolicy.wisc.edu/internat/model_law_eval.pdf
(accessed February 6, 2009).

[99] 72 percent of
governments participating in the survey cited concerns about addiction to
opiates. INCB, "Availability of Opiates for Medical Needs: Report of the
International Narcotics Control Board for 1995," p. 5.

[112] Scott Burris
and Corey S. Davis, "A Blueprint for Reforming Access to Therapeutic Opioids:
Entry Points for International Action to Remove the Policy Barriers to Care,"
(Centers for Law and the Public's Health: A Collaborative at the Johns Hopkins
and Georgetown Universities, 2008), p.16.

[113] See for example
INCB, "Report of the International Narcotics Control Board for 2007," p. 19.

[114] INCB, "Report of
the International Narcotic Control Board for 1990."

[131] In March 2009, a
new regulation will come into force in Guatemala that abolishes these
requirements. Personal communication with Dr. Eva Duarte, January 23, 2009.

[132] Scott Burris and
Corey S. Davis, "A Blueprint for Reforming Access to Therapeutic Opioids: Entry
Points for International Action to Remove the Policy Barriers to Care" (Centers
for Law and the Public's Health: A Collaborative at the Johns Hopkins and
Georgetown Universities, 2008), p.18.

[133] Ministry of
Health of Vietnam, "Palliative Care in Viet Nam: Findings of A Rapid Situation
Analysis in Five Provinces," June 2006, p. 36.

[153] Scott Burris
and Corey S. Davis, "A Blueprint for Reforming Access to Therapeutic Opioids:
Entry Points for International Action to Remove the Policy Barriers to Care"
(Centers for Law and the Public's Health: A Collaborative at the Johns Hopkins
and Georgetown Universities, 2008), p.18.

[154] Kathleen M.
Foley, et al., "Pain Control for People with Cancer and AIDS," p.
988.

[166] While this is an
improvement, patients and their families can only fill prescriptions for ten
days at a time, after which their local commune must confirm in writing that
the patient is still alive.

[167] For example,
patients must fill their prescription within one day, otherwise it becomes
invalid. This is burdensome under any circumstances but particularly as few
pharmacies and hospitals in Vietnam stock oral morphine.